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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Non guideline study but sufficiently documented reliable methodology

Data source

Reference
Reference Type:
publication
Title:
First epidemiological study of contact dermatitis in Spain-1977. Spanish Contact Dermatitis Research Group
Author:
CAMARASA, J.M
Year:
1979
Bibliographic source:
Acta Derm. Venereol. [Suppl.] (Stockh.) 59(85), 33-7
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Repeated Insult Patch Tests (HRIPT) Patch-tested according to Standard International Contact Dermatitis Research Group (ICDRG) Procedure
GLP compliance:
not specified
Type of study:
open epicutaneous test
Justification for non-LLNA method:
No new test performed as clinical data are already available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

In vivo test system

Test animals

Species:
other: human patients of dermatologists
Sex:
male/female
Details on test animals and environmental conditions:
During year 1977, 2806 patients were studied with patch test among 30873 dermatological patients. Four major groups of allergens were able to consider, following the incidence in their power of sensitize. Third groups with medium incidence contains Benzalkonium chloride in particular.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Concentration / amount:
0.1%
Challenge
Route:
epicutaneous, open
Concentration / amount:
0.1%
No. of animals per dose:
2806 patients who had been diagnosed with eczema suspect of contact etiology
Details on study design:
To each patient we applied the Spanish standard patch rests, based on the o nes used by the I. C. D. R. G. with the addition of some ext ra noxas, which are still widely resorted to in Spain. We used the Al-Test patch produced by the "lmeco Astra Agency Co." -Sweden-, the "Microspore Surgical 1530" tape and the "Staedtler Noris 323" porous-pen.
Challenge controls:
Four major groups of allergens were able to consider,following the incidence in their power of sensitize. First group with strong incidence include: Nickel, Chromate, Cobalt, T. M. T. D., P. P. D. A., Mercapto mix. , and Wood tars. Second and third groups with medium incidence contain: Caines, Carbonates, Neomycin, Balsam of Peru, Mercury, Lanolin, Naphtyl mix ., Formaldehyde, Benzalkonium chloride, P. P. D. A. mix, and Turpentine. Four group show very low incidence substances, as: Epoxi, Sulfonamides, Et ilendiamine, Parabens, Chinoform, Colophony and Cinnamon oil.
Positive control substance(s):
yes

Results and discussion

Positive control results:
Benzalkonium chloride: index of sensitization observed in 60 cases on 2806 (2,13%)

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
2nd reading
Hours after challenge:
96
Group:
test group
Dose level:
0.1%
No. with + reactions:
66
Total no. in group:
2 086
Clinical observations:
positive sensitization, not specified
Remarks on result:
positive indication of skin sensitisation
Remarks:
2.13% in 2806 patients who had been diagnosed with eczema suspect of contact etiology
Reading:
2nd reading
Hours after challenge:
96
Group:
negative control
Dose level:
0.1% pet. for benzalkonium chloride, up to 25% for other chemicals tested
No. with + reactions:
1 701
Total no. in group:
2 806
Clinical observations:
positive sensitization to one of the chemicals tested, not specified
Remarks on result:
no indication of skin sensitisation
Remarks:
Patients with negative reactions to all patches: 1105 (39,37%).
Reading:
2nd reading
Hours after challenge:
96
Group:
positive control
Dose level:
0.1% pet. for benzalkonium chloride, up to 25% for other chemicals tested
No. with + reactions:
1 701
Total no. in group:
2 806
Clinical observations:
positive sensitization to one of the chemicals tested, not specified
Remarks on result:
positive indication of skin sensitisation
Remarks:
Patients with one or more positivities: 1701 (60,62%)

Applicant's summary and conclusion

Conclusions:
In a repeated patch tested according to Standard International Contact Dermatitis Research Group procedure (HRIPT), 66 of the 2806 were sensitive to Benzalkonium Chloride (2.13%)
Executive summary:

Patch tested according to Standard International Contact Dermatitis Research Group procedure, 66 of the 2806 eczema patients were sensitive to Benzalkonium Chloride